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New Search Back To Search Results Device devices, breath trapping, alcohol Regulation Description Breath-alcohol test system. Regulation Medical Specialty Toxicology Review Panel Toxicology Product Code DJZ Submission Type 510(k) Regulation Number 862.3050 Device Class 1 GMP Exempt? No Third Party Review Eligible for Accredited Persons Program Accredited Persons british standards institution center for measurement standards of industrial cheiroon bv citech intertek testing services regulatory technology services, llc tuv rheinland of north america, inc. tuv sud america inc. underwriters laboratories, inc.